Clinical trials with recruitment HEMATOONCOLOGY CLINIC

Transcription

1 Clinical trials with recruitment

2 Dg. Title Arms MM Panorama 3 Panobinostat, Bortezomib, Dexamethasone AGMT EMN-13 Ixazomib, Thalidomid, Dexamethasone R/R PCYC-1138 Ibrutinib, Pomalidomid, Dexamethasone PCYC-1139 Ibrutinib, Velcade, Dexamethasone EMN11/HO114 Carfilzomib, Pomalidomide, Dexamethasone CA Nivolumab, Elotuzumab, Pomalidomide, Dexamethasone MT C16021 MLN9708 vs. placebo

3 New diagnosis C UT Relapsed PCYC-1138-CA CLBH589D2222 (Panorama3) PCYC-1139-CA AGMT_MM-1/EMN-13 CA EMN11/HO114 only for patients of EMN02 study

4 A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Maintenance Therapy After Initial Therapy in Patients With Newly Diagnosed Multiple Myeloma Not Treated With Stem Cell Transplantation.

5 completed 6 to 12 months of initial therapy with documented major response PR, VGPR, CR (maintained for 2 cycles after the M-protein nadir is reached) not eligible for ASCT ECOG 0-2 relapsed/not responsive MM to initial therapy prior stem-cell transplantation radiotherapy within 14 days before randomization Diagnosis of Waldenstrom's macroglobulinemia, POEMS

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7 A Randomized Multicenter Study of Ibrutinib in Combination with Pomalidomide and Dexamethasone in Subjects with Relapsed/Refractory Multiple Myeloma.

8 relabující MM refrakterní MM nejméně 2 předchozí linie léčby MM včetně LEN a buď léčba s Bortezomibem nebo CFZ PD na léčbě nebo do 60 dní od ukončení léčby ECOG max. 2 primárně refrakterní onemocnění předchozí léčba Pomalidomidem (výjma ramene C), BTK inhibitory syndrom POEM periferní neuropatie 2 a vyšší grade signifikantní GIT onemocnění

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10 A multicenter, randomized, open-label Phase 2 study evaluating the safety and efficacy of three different regimens of oral panobinostat in combination with subcutaneous bortezomib and oral dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma who have been previously exposed to immunomodulatory agents.

11 relapsed or relapsed and refractory mm 1-3 prior lines of therapy measurable disease ECOG 0-2 prior IMiD exposure laboratory values within normal range primary refractory MM refractory to bortezomib prior treatment with DAC inhibitors including Panobinostat diarhea grade 2 and higher gastrointestinal dysfunction

12 Screening Randomizace Arm A: PAN 20 mg TIW (D 1, 3, 5, 8, 10, 12) BTZ: C1-C4: 75 years: BTZ:1.3 mg/m2 (D1, 4, 8 & 11); > 75 yrs OW (D1, 8) C5+: BTZ 1.3mg/m2 QW (D1,8) Dexa : 20 mg/day for patients 75years of age on 1st day of screening; 10 mg/d for patients > 75 years of age on 1st day of screening; On the day of BTZ treatment (about minutes prior to BTZ s.c. injection) and the day after BTZ treatment. Arm B: PAN 20 mg BIW (D 1, 4, 8, 11) BTZ: C1-C4: 75 years: BTZ:1.3 mg/m2 (D1, 4, 8 & 11); > 75 yrs OW (D1, 8) C5+: BTZ 1.3mg/m2 QW (D1,8) Dexa : 20 mg/day for patients 75years of age on 1st day of screening; 10 mg/d for patients > 75 years of age on 1st day of screening; On the day of BTZ treatment (about minutes prior to BTZ s.c. injection) and the day after BTZ treatment. Arm A: PAN 10 mg TIW (D 1, 3, 5, 8, 10, 12) BTZ: C1-C4: 75 years: BTZ:1.3 mg/m2 (D1, 4, 8 & 11); > 75 yrs OW (D1, 8) C5+: BTZ 1.3mg/m2 QW (D1,8) Dexa : 20 mg/day for patients 75years of age on 1st day of screening; 10 mg/d for patients > 75 years of age on 1st day of screening; On the day of BTZ treatment (about minutes prior to BTZ s.c. injection) and the day after BTZ treatment. Follow-up prior PD every 6 weeks post PD every 12 weeks

13 An Open-label study of Ibrutinib in Combination with Bortezomib and Dexamethasone in Subjects with Relapsed or Relapsed and Refractory Multiple Myeloma.

14 relapsed MM or relapsed and refraktory MM prior bortezomib exposure received 1-3 prior lines of therapy with demonstrated PD since completion of the most recent treatment regiment SPEP more than 1 g/dl IgG, others more than 0.5 g/dl ECOG max. 2 primary refraktory disease prior exposure to BTK inhibitors syndrom POEM prior allogeneic cell transplant peripheralneuropathy grade 2 or higher

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16 Ixazomib in Combination with Thalidomide Dexamethasone in patients with relapsed and/or refractory multiple myeloma.

17 relapsed or refractory MM at least 1 prior line of therapy measurable disease GFR nad 15 ml/min (MDRD) ECOG max. 2 previous treatment with bortezomib nebo thalidomide within the last 3 months prior to baseline visit primary refractory MM prior treatment with Ixazomib neuropathy 3 and higher

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19 An Open-Label, Randomized Phase 3 Trial of Combinations of Nivolumab, Elotuzumab, Pomalidomide and Dexamethasone in Relapsed and Refractory Multiple Myeloma.

20 double refractory = refractory to PI and IMID or relapsed nad refractory = previous treatment with PI or IMID, or both, but Pdwithin 6 months, and refractory to theri last treatment measurable disease 2 or more prior lines with IMID and PI solitary bone or extramedullary plasmocytoma as the only evidence of plasma cell dyscrasia syndrome POEM prior exposure nivolumab, pomalidomide, elotuzumab NYHA III, IV

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22 Pomalidomide combined with Carfilzomib and Dexamethasone (PCd) for induction and consolidation followed by Pomalidomide combined with Dexamethason vs Pomalidomide maintenance for patients with Multiple Myeloma in progression after prior 1st line treatment with Lenalidomide and Bortezomib.

23 included in EMN02 trial measurable disease documented PD or refractory MM as per IMWG criteria WHO 0, 1, 2 recieved more than 1 line of therapy, except local radiotherapy syndrome POEM previous therapy with pomalidomide or carfilzomib LVEF no higher than 40 % NYHA III or IV

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25 Thank you.